More than two-and-a-half years after issuing proposed regulations under the Health Information Technology for Economical and Clinical Health (HITECH) Act, on January 17, 2013, HHS released a series of final changes to its Privacy, Security, Breach Notification and Enforcement Rules promulgated under the Health Insurance Portability and Accountability Act (HIPAA). While the agency also supports changes required by the Genetic Information Nondiscrimination Act (GINA), the long-awaited final rules show little change over its proposals, other than a notable update to the Breach Notification Rule.

Specifically, as predicted by many in the privacy community, the agency restructured the Breach Notification Rule’s rather subjective “harm threshold” used for determining when a breach occurs and notification is required. Under the final rule, most unauthorized acquisitions, accesses, uses or disclosures of protected health information (PHI) are presumed to be breaches, save a few narrow exceptions. To avoid making notifications, covered entities must now “demonstrate that there is a low probability that the protected health information has been compromised” using at least four specified factors that the agency characterizes as more “objective.”

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